AKIS 25 MG/ML SOLUTION FOR INJECTION

Transcript

PACKAGE LEAFLET: INFORMATION FOR THE USER
AKIS 25, 50 and 75 mg/ml solution for injection
Diclofenac sodium
Read all of this leaflet carefully before you start using this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet Akis 25, 50 and 75 mg/ml solution for injection will be referred to as Akis.
In this leaflet:
1.
What Akis is and what it is used for
2.
Before you use Akis
3.
How to use Akis
4.
Possible side effects
5.
How to store Akis
6.
Further information
1.

WHAT AKIS IS AND WHAT IT IS USED FOR

Akis contains the active substance diclofenac sodium. Akis belongs to a type of medicine called a
non steroidal anti-inflammatory drug (NSAID). Other NSAIDs include aspirin and ibuprofen. These
drugs reduce pain and inflammation.
Akis is used to treat a number of painful conditions including:
•
•
•
•
•
2.

Flare-ups of joint or back pain
Attacks of gout
Pain caused by kidney stones
Pain caused by injuries, fractures or trauma
It is also used to treat pain following an operation.

BEFORE YOU USE AKIS

Do not use Akis:
• If you are allergic to diclofenac, aspirin, ibuprofen or other NSAIDs.
• If you are allergic to any of the other ingredients of Akis (they are listed in section 6 at the end
of this leaflet)
• If you have a history of bleeding in your stomach or bowels after you have taken NSAIDs
• If you have had two or more episodes of stomach (gastric) or duodenal (peptic) ulcers or
bleeding in the digestive tract. (This may include blood in vomit, bleeding when emptying the
bowels, or black, tarry stools)
• If you have, or have had liver failure
• If you have, or have had severe heart failure

1

• If you have established heart disease and /or cerebrovascular disease e.g. if you have had a heart
attack, stroke, mini-stroke (TIA) or blockages to blood vessels to the heart or brain or an
operation to clear or bypass blockages
• If you have or have had problems with your blood circulation (peripheral arterial disease)
• If you have, or have had severe kidney failure
• If you have asthma, hives or acute rhinitis (allergy) which are caused by use of NSAIDs or
aspirin
• If you have a blood clotting disorder or are currently taking anticoagulants (such as warfarin)
• If you are more than 6 months pregnant
• If you are under 18 years of age
Take special care with Akis
Make sure your doctor knows, before you are given diclofenac
• If you smoke
• If you have diabetes
• If you have angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides
Side effects may be minimised by using the lowest effective dose for the shortest duration
necessary.
Tell your doctor before you are given Akis:
• If you have ever had an ulcer in the gullet, stomach or upper bowel, or gastrointestinal bleeding.
Symptoms of which may include blood in vomit or when emptying bowels or black, tarry stools
• If you suffer from any bowel disorders including ulcerative colitis or Crohn’s disease
• If you have, or have ever had, kidney or liver problems
• If you have had a history of or suffer from any blood or bleeding disorders
• If you have, or have ever had asthma, chronic obstructive pulmonary disease (COPD), nasal
polyps or hay fever
• If you have lupus (systemic lupus erythematosus or SLE) or any similar problem
• If you are planning to become pregnant, as Akis may interfere with your ability to become
pregnant.
Other special warnings
• Medicines such as Akis may be associated with a small increased risk of heart attack
(“myocardial infarction”) or stroke. Any risk is more likely with high doses and prolonged
treatment. Do not exceed the recommended dose or duration of treatment
• Akis is an anti-inflammatory medicine, therefore it may reduce the symptoms of infection, such
as headache or high temperature. If you feel unwell and need to see a doctor, remember to tell
him or her you are taking Akis
• Elderly patients are more prone to the side effects associated with Akis so tell your doctor about
any unusual symptoms.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription (e.g. over-the-counter medicines or those for
recreational use). Some medicines may interfere with your treatment.

2

Tell your doctor if you are taking any of the following medicines:
• Any other NSAID or COX-2 (cyclooxygenase-2) inhibitor, for example aspirin or ibuprofen
(medicines for inflammation or pain)
• Medicines to treat diabetes
• Anticoagulants (blood thinning tablets like warfarin or heparin)
• Antiplatelet medicines (to prevent blood clots)
• Diuretics (water tablets)
• Lithium (a medicine to treat some types of depression)
• Phenytoin (a medicine to treat epilepsy)
• Cardiac glycosides (e.g. Digoxin; medicines for heart problems)
• Methotrexate (a medicine for some types of inflammation and cancers)
• Ciclosporin and tacrolimus (medicines for some types of inflammation and after organ
transplants)
• Quinolone antibiotics (medicines used to treat some infections)
• Steroids (medicines for inflammation and for treating immune system problems)
• Colestipol (a medicine used to reduce cholesterol)
• Cholestyramine (a medicine used to treat liver problems and Crohn’s disease)
• Sulfinpyrazone (a medicine used to treat gout)
• Voriconazole ( a medicine used to treat fungal infections)
• Pemetrexed (a chemotherapy drug used to treat some forms of cancer)
• Deferasirox (a medicine used in patients having long term blood transfusions)
• Mifepristone (a medicine used during termination of pregnancy)
• Medicines for heart problems or high blood pressure, for example beta blockers or ACE
inhibitors
• Medicines used to treat anxiety and depression known as serotonin re-uptake inhibitors (SSRIs)
• Zidovudine (a medicine for human immunodeficiency virus (HIV) infection).
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
• Akis may make it more difficult to become pregnant. You should talk to your doctor if you are
having problems getting pregnant
• You must tell your doctor if you are pregnant or planning to become pregnant as they will
consider if Akis should be used
• Akis must not be used if you are more than 6 months pregnant as it may affect the baby’s
circulation or damage your baby’s kidneys, and delay or prolong your labour
• You must tell your doctor if you are breast-feeding. If you are breast-feeding your doctor will
consider if Akis should be used.
Driving and using machines
Akis may make some people feel dizzy, tired, sleepy or have blurred vision. Do not drive or use any
tools or operate machines if you are affected in this way.
3.

HOW TO USE AKIS

Your doctor will decide when and how to treat you with Akis solution for injection. You will either
be given an intramuscular injection (an injection into a muscle usually into the buttocks) or a
subcutaneous injection (an injection into the skin usually into the buttocks or thigh). Akis must not
be given by intravenous (i.v.) administration.

3

Adults: The usual starting dose is 25 to 75mg depending on the severity of your pain. If you are
still in severe pain, your doctor may decide to give you a second injection after 6 hours. The
maximum daily dose is 150 mg. You will only be given Akis for one or two days.
Elderly: Your doctor may give you a dose that is lower than the usual adult dose if you are elderly.
Children: Not suitable for children (under 18 years).
A doctor, nurse or pharmacist will prepare the injection for you. A nurse or doctor will usually then
give you the injection. Your doctor or nurse will not inject you in the same place twice.
If you use more Akis than you should
If you have been given too much Akis you may experience the following symptoms: feeling and
being sick, stomach pain, stomach and or bowel bleeding, rarely diarrhoea, dizziness, tinnitus
(buzzing, hissing, ringing, whistling or other persistent noises in the ear and occasionally
convulsions (fits or seizures). In severe cases, your kidneys or liver may be damaged (symptoms
include having difficulty passing water or passing more water than usual, muscle cramps, tiredness,
swelling in your hands, feet or face, feeling or being sick, yellowing of your skin).
If you think you have been given too much AKIS immediately tell your doctor or nurse.
4.

POSSIBLE SIDE EFFECTS

Like all medicines, Akis can cause side effects, although not everybody gets them.
Tell your doctor immediately if you get any of the following:
• Severe allergic reactions which may include: swelling of face, throat or tongue, breathing
difficulties, wheezing, runny nose and skin rashes
• Stomach pain, indigestion, heartburn, wind, feeling sick or being sick
• Any sign of bleeding in the stomach or intestine, for example, blood when emptying your
bowels, black, tarry stools or blood in vomit
• Serious skin rashes, itching, hives, bruising, painful red areas, peeling or blistering of skin, giant
wheals (burning itchy swollen skin). These conditions may also affect mouth, lips, eyes nose
and genitals
• Yellowing of your skin or the whites of your eyes
• Persistent sore throat or high temperature
• An unexpected change in the amount of urine produced and/or its appearance.
• Bruising more easily than usual or having frequent sore throats or infections.
Very common side effects (likely to affect up to 1 in 10 patients)
• Pain, redness or lumps at the injection site
Common side effects (likely to affect between 1 in 100 and 1 in 10 patients)
• Feeling sick
Uncommon side effects (reported 1 in 1000 to 1 in 100)
• Dizziness and headache
• Diarrhoea, being sick and constipation
• Inflammation of stomach lining causing stomach pain, sickness and loss of appetite
• Liver problems
4

• Skin rash, itching.
Other side effects
The following list of side effects have been reported in patients treated with NSAIDs.
Effects on the heart, chest or blood
• Medicines such as Akis may be associated with a small increased risk of heart attack
(“myocardial infarction”) or stroke
• High blood pressure, heart attack, fast or irregular heartbeat, chest pain and swelling of body,
hands or feet
• Asthma, breathlessness
• Blood disorders such as anaemia (decreased number of red blood cells). Symptoms include
tiredness, headache, dizziness, looking pale.
Effects on stomach and digestive system
• Peptic (stomach) ulcers, mouth ulcers, tongue infections, lower gut disorders (including
inflammation of gut and worsening of Crohn's disease)
• Inflammation of pancreas or stomach lining (symptoms of which include severe stomach pain
which may extend to your back or shoulder).
Effects on nervous system
• Tingling or numbness, pins and needles of the hands or feet or limbs, tremors, blurred or double
vision, hearing loss or impairment, tinnitus (ringing in the ears), drowsiness, tiredness
• Hallucinations (seeing or hearing things that are not there), depression, disorientation, sleep
problems, irritability, anxiety, memory problems and convulsions (fits or seizures).
• Inflammation of the layers lining the brain. Symptoms of which include stiff neck, headache,
nausea, vomiting, fever or disorientation and extreme sensitivity to bright light.
Effects on liver and kidney
• Liver disorders. Symptoms may include sickness, loss of appetite, generally feeling unwell,
sometimes with jaundice
• Kidney disorders or kidney failure. Symptoms include blood in urine, frothy urine, swelling of
feet and hands or body.
Effects on skin and hair
• Serious skin rashes such as Stevens-Johnson syndrome and other skin conditions which may be
made worse by exposure to sunlight
• Hair loss.
If any of the symptoms get serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
5.

HOW TO STORE AKIS

• Keep this medicine out of the sight and reach of children
• Do not use Akis after the expiry date which is stated on the ampoule as “EXP” (the expiry date
refers to the last day of that month)
• Store below 25oC. Do not refrigerate or freeze. Store in the original package in order to protect
from light
5

• Use immediately after opening. Discard any unused product
• Do not use the medicine if it is cloudy or if any small bits can be seen.
After injection of the correct dose your doctor or nurse will dispose of any solution that remains,
along with the syringe, needles and containers.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away any medicines you no longer use. These measures will help protect the environment.

6.

FURTHER INFORMATION

What Akis contains
The active substance is: diclofenac sodium.
Each 1 ml ampoule contains:
25 mg of diclofenac sodium or
50 mg of diclofenac sodium or
75 mg of diclofenac sodium
The other ingredients are: hydroxypropyl-beta-cyclodextrin, polysorbate 20, water for injections.
What Akis looks like and contents of pack
This medicinal product is a clear to slightly amber coloured transparent solution for injection
contained in a clear glass container (ampoule).
Pack size of 1, 3 and 5 ampoules.
This medicinal product is also supplied as a prefilled syringe.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
IBSA Farmaceutici Italia Srl
Via Martiri di Cefalonia 2
26900 Lodi (Italy)
This leaflet was last updated in 07/2015
If this leaflet is difficult to see or read or you would like it in a different format, please contact
IBSA Farmaceutici Italia Srl, Via Martiri di Cefalonia 2, 26900 Lodi, Italy (Tel +39(0)
371617292, Email: info@ibsa.ch)

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.